FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
KOLPEXIN SPHERE
K Number: K032644
·
Decision May 28, 2004
Classifications
1
FEI Numbers
40
Registration Numbers
40
Same Product Code
40
Applicant Total
1
Review Days
275
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Basic Information
- Device Name
- KOLPEXIN SPHERE
- K Number
- K032644
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 884.3575
- Medical Specialty
- Obstetrics/Gynecology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Adamed , Ltd.
- Date Received
- August 27, 2003
- Decision Date
- May 28, 2004
- Product Code
- HHW
- Advisory Committee
- Obstetrics/Gynecology
- Review Advisory Committee
- OB
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| HHW | Pessary, Vaginal | FDA class 2 | Obstetrics/Gynecology |
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